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A phase 3, double-blind, placebo-controlled study of an investigational medication as adjunctive therapy in major depressive disorder

Clinical Trial Protocol ID:

13060605

Clinical Trial Investigator Name:

Corey Goldstein, MD

Clinical Trial Protocol Description:

This is an 18- to 19-week study in patients with major depressive disorder who have an inadequate response to certain other antidepressants. The study will include a one- to two-week screening period, followed by an eight-week, open-label period of treatment with an antidepressant, followed by an eight-week, double-blind treatment period with the investigational medication or placebo added to the antidepressant therapy, followed by a one-week safety follow-up period. A 26-week open-label extension study may also be available to those who complete the lead-in study.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

Are 18-65 years of age.

Have major depressive disorder, with current episode lasting between two and 12 months.

Have failure to an adequate trial of an antidepressant during the current depressive episode.

You will be excluded from the study if any of the following criteria apply to you:

Have certain other diagnoses.

Have a history of ECT and/or certain other treatments during the current episode or within 6 months of study.

Have current, or history of, substance use or dependence.

Have certain other medical conditions.

Have current, or history of, cataracts, eye surgery, laser treatment.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided.